Kornimate/medical-research-clean huggingface dataset:
a phase 1/2a study evaluating allocetra-ots as monotherapy or in combination with anti-pd-1 therapy for the treatment of advanced solid tumor malignancy

Conditions: Solid Tumor; Peritoneal Metastases; Peritoneal Cancer

Summary: this is an open-label, non-randomized, multicenter, phase 1/2a study to evaluate the safety and potential efficacy of allocetra-ots in the treatment of advanced solid tumor malignancy as monotherapy or in combination with an anti-pd-1 therapy.

despite the advent of novel targeted and immunotherapeutics for the treatment of solid tumors, many patients remain without cure. allocetra-ots is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state. this is an open-label, non-randomized, multicenter, phase 1/2a study to evaluate the safety and potential efficacy of allocetra-ots in the treatment of advanced solid tumor malignancy as monotherapy (stage 1), and in combination with an anti-pd-1 therapy (stage 2). allocetra-ots will be administered systemically or locally (intravenous \[iv\] or intraperitoneal \[ip\]) according to the tumor location.

Eligibility criteria:
inclusion criteria: 1. patients must have histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumors, that have relapsed or have been refractory to available approved therapies, or patients who are not eligible for or declined additional standard of care systemic therapy. patients with peritoneal carcinomatosis can be eligible if an appropriate ip catheter or port can be placed. 2. patients must have measurable disease. 3. age ≥ 18 years old. 4. ecog performance status ≤1. 5. adequate renal function, hepatic function, and bone marrow function. exclusion criteria: 1. primary central nervous system (cns) malignancy or cns involvement, unless stable clinically. 2. clinically significant uncontrolled infection, autoimmune or inflammatory diseases requiring systemic immunosuppression, clinically significant cardiovascular disease, severe pulmonary diseases or additional malignancies. 3. \[for patients in stage 2\] patients who previously experienced an ici-related adverse reaction that resulted in discontinuation of the ici.
the healthy eating choices for life program

Conditions: Obesity

Summary: the purpose of this investigation is to conduct a 12-week pilot study to examine the effect of three different dietary prescriptions that differ on targeting reducing energy density (kcal/gram) and energy (kcal) on overall dietary intake, hunger, feelings of deprivation, satisfaction with the diet, mood, and weight loss in 45 overweight/obese adults receiving a 12-week behavioral weight loss intervention.

given the current prevalence of overweight and obesity among adults in the united states and the projected increase of these conditions in the future, development of effective weight loss and weight loss maintenance strategies is imperative. for weight loss to occur, energy intake needs to be reduced to incur an energy deficit, and for successful weight loss maintenance, energy intake needs to remain lower than energy intake at pre-weight loss levels due to an overall reduction in body size which reduces basal metabolic rate. one dietary strategy that may facilitate weight loss maintenance is consuming a diet low in dietary energy density (ed). this pilot study will test the effects of a dietary prescription focused on ed. all participants in the investigation will receive a standard 12-week behavioral obesity intervention. the intervention will include an activity goal that participants will gradually work to achieve over the course of the 12-week intervention along with standard behavioral weight loss strategies. one condition will receive a dietary prescription for weight loss that focuses solely on lowering the ed of the diet, another condition will receive the traditional dietary prescription used in behavioral weight loss interventions that reduces energy intake, and the third condition will receive both prescriptions. pre and post intervention measurements will be taken to determine if there are differences between groups.

Eligibility criteria:
inclusion criteria: * age between 21 and 65 years * body mass index (bmi) between 25 and 45 kg/m2 exclusion criteria: * report a health condition on the physical activity readiness questionnaire (par-q) * report being unable to walk for 2 blocks (1/4 mile) without stopping * report major psychiatric diseases/organic brain syndromes via a phone screen * are currently participating in a weight loss program and/or taking weight loss medication or lost \> 5% of body weight during the past 6 months * intend to move to another city within the time frame of the investigation * are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation * have had gastric surgery for weight loss

Keywords: weight dietary intake energy density behavioral satiety deprivation hunger fruit vegetable
treatment of neuroleptic induced acute akathisia with trazodone

Conditions: Schizophrenia

Summary: administration of trazodone for the treatment of neuroleptic induced acute akathisia in a cross-over fashion of 6 days duration. 3 days of placebo and 3 days of trazodone.


Eligibility criteria:
inclusion criteria: * patients with akathisia according to dsm-iv criteria at least mild akathisia. exclusion criteria: * change of pharmacologic regimen 7 days prior to study entry * significant systemic disease * the presence of chronic akathisia * patients unable to cooperate
probiotics as adjunct to nonsurgical periodontal treatment

Conditions: Periodontitis

Summary: prolacsan probiotic lozenges and gels contain l. plantarum and l. brevis strains with proven in vitro antimicrobial activity against p. gingivalis. in our study we aim to investigate proposed benefit of prolacsan as adjunct to conventional initial periodontal treatment in a group (n = 40) of grade iii and iv periodontitis patients. patients will be randomized in two groups receiving either probiotic (n = 20) or placebo (n = 20) after completion of nonsurgical treatment within 7 days. before treatment and after three months, standard periodontal parameters will be measured by masked examiner and plaque samples harvested for cultivation of 9 most relevant periodontal pathogens. one lozenge per day of probiotic/placebo will be used during 3 months healing period. primary outcome measures will be the number of persisting sites per patient that need additional surgical treatment defined as sites with probing depth \> 4 mm and bleeding on probing.


Eligibility criteria:
inclusion criteria: * periodontitis stage iii or iv * at least 20 teeth for evaluation * besides solitary crowns, no other prosthodontic tooth replacements * good systemic health * smoking less than 10 cig/day exclusion criteria: * periodontal treatment lass than 1 year before inclusion * antibiotic therapy in the last 6 months * chronic systemic diseases with the impact on periodontium or healing process * medication with the impact on periodontium or healing process

Keywords: periodontitis probiotic non-surgical therapy
plaque removal effectiveness of a flossing device compared to the conventional flossing in adults

Conditions: Tooth Decay; Cavities of Teeth; Gingivitis; Plaque

Summary: * objective: to evaluate the effectiveness in plaque removal of the new device; dental floss holders and compare the results to the conventional way of flossing. * methods: thirty adult male and female participants participated in this randomized, single-use, single-blind clinical study. participants were randomly assigned to one of two groups; group a: consists of 30 participants in whom dental floss holders (dfh) was constructed to either maxillary or mandibular arch randomly. group b: consists of 30 participants in whom conventional flossing (cf) was done to the other arch. participants attended the first visit for primary impression taking in order to construct the dfh. in the second visit, participants were examined by a blinded examiner to record their plaque index using o'leary index. then, they flossed using dfh and cf according to the group they were assigned to. participants were monitored to ensure proper coverage of all the areas following precise instructions. they then brushed their teeth for approximately 2 minutes using modified bass technique. next, plaque index was recorded again using the o'leary index. time was recorded during flossing of each arch. finally, participants were given a questionnaire to assess their satisfaction of the device. * results: the differences between the groups showed the dfh group with a 62.8% reduction in whole mouth plaque and 63.3% for proximal plaque compared to 52.9% and 50.4% for the cf group, respectively (p = 0.01). the dfh was more time efficient in removing plaque from the marginal regions with an average time of 00:00:37 in comparison to the cf which averaged in 00:02:07 (p \< 0.001). a total of 26 participants (86.7%) preferred using the dfh over the cf. * conclusion: with the combination of toothbrushing, the dental floss holders is significantly more effective and time efficient than conventional flossing in removing plaque from tooth surfaces.


Eligibility criteria:
1. able to understand, read, and write in arabic or english and provide written informed consent prior to participation. 2. not engaged in any other clinical study during the day of examination. 3. non-smoker and in good general health. 4. does not have any systemic disease that influences the oral tissue (e.g., diabetes, autoimmune disease, medication/antibiotics). 5. fully dentate (not including 3rd molars) with established proximal contacts. 6. good oral health with no hard or soft tissue lesions, no gross caries, no probing depths greater than 4 mm, no obvious advanced periodontal disease, no fixed orthodontic appliances, nor removable partial dentures. 7. does not have any dexterity limitation. 8. not pregnant at the time of the study.

Keywords: plaque removal flossing device
a pilot study investigating the impact of different iol designs on subjective 2d and 3d image quality

Conditions: Lenses; Intraocular Sensitivity; Visual Acuity

Summary: the who, states that age related cataracts account for 51 percent of worldwide blindness and affect about 20 million people. surgery with intraocular lens (iol) implantation is the first line treatment for cataracts, thus there is an on going effort to improve iol design and performance. it is planned to compare three different iol designs in a psychophysical test setting. most iol testing is done in 2d scenarios such as early treatment diabetic retinopathy study (etdrs) visual acuity or contrast sensitivity testing. the use of 3d scenario would allow testing a more real-life situation. as various downsides of different iol designs have been reported, testing of iols before surgical implantation is a promising approach to maximise patient satisfaction. known deficiencies include amongst others reduced contrast sensitivity or light intensity. to test three different iol designs, it is planned to have 2d healthy young subjects look through a stable, table mounted spectacle frame, in which the different iols can be inserted. this allows for subjective testing of iol's in a 2d and 3d scenario.


Eligibility criteria:
inclusion criteria: * men and women aged between 18 and 35 years * normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant * normal ophthalmic findings * refractive spherical error between between -1 and +1 diopters, refractive cylindrical error between -0,25 and +0,25 diopters * dominant eye : right eye ( used as study eye) exclusion criteria: * abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study * symptoms of a clinically relevant illness in the 3 weeks before the first study day

Keywords: iol
pilot trial of pre-operative chemo/rt using xeloda and external beam rt followed by definite surgery in patients with localized rectal ca

Conditions: Rectal Neoplasms

Summary: pilot trial of pre-operative chemo/rt using xeloda and external beam rt followed by definite surgery in patients with localized rectal ca


Eligibility criteria:
inclusion criteria: * patients with localized rectal ca

Keywords: pilot trial of pre-operative chemo/rt using xeloda and external beam rt followed by definite surgery in patients with localized rectal ca
prediction and prevention of twin premature birth 2021

Conditions: Preterm Birth

Summary: research objectives: 1. establish a prediction and scoring system for twin premature birth. 2. to investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth. 3. to investigate the effect of stress cervical ligation in preventing premature delivery of twins. 4. the optimal dose of atosiban for the treatment of twin premature birth. 5. the influence of delivery mode on twin premature infants under 32 weeks.

research objectives: 1. establish a prediction and scoring system for twin premature birth. 2. to investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth. 3. to investigate the effect of stress cervical ligation in preventing premature delivery of twins. 4. the optimal dose of atosiban for the treatment of twin premature birth. 5. the influence of delivery mode on twin premature infants under 32 weeks. it has now entered the second phase: clinical data collection

Eligibility criteria:
inclusion criteria: twins with cervical length ≤ 25 mm by vaginal ultrasound at 14-32 weeks no contractions, abdominal pain and vaginal bleeding no complicated twin complications occurred during pregnancy exclusion criteria: patients undergoing selective cervical ligation before 14 weeks of gestation history of liver problems or cholestasis during pregnancy abnormal liver enzymes abnormal renal function local allergy to trace natural progesterone recurrent vaginal bleeding recurrent vaginal infection ultrasound diagnosis of fetal abnormality intrauterine treatment for fetal abnormalities
practice analysis of care, paraclinical exams and treatments received by geriatric patients both during the last week and the last 24 hours of their lives.

Conditions: End-of-life Care

Summary: end-of-life care is a core topic for geriatricians. one of the key aspects of end-of-life management is deciding when to discontinue active care measures (for example blood pressure monitoring, blood tests and x-rays) in favor of exclusive comfort care. in this retrospective observational study, the investigators looked at the care measures, treatments and paraclinical exams received by geriatric patients both one week and 24 hours before their death.

this analysis provides information on the differences in geriatric physicians' practices regarding the anticipation of the end of life, by showing on average when active care measures were stopped before death. secondly, the investigators looked at patient criteria that could explain a prolongation of active care and a delay in the implementation of exclusive comfort care.

Eligibility criteria:
inclusion criteria: * all patients over 75 years old who died in a geriatric short-stay department at saint-etienne university hospital. exclusion criteria: - patients under 75 years old

Keywords: end of life care geriatric death
evaluation of clinical impact of the type of cardioplegia used in the patient undergoing major cardiac surgery.

Conditions: Cardiac Surgery; Cardioplegia; Heart Arrest

Summary: phase iv clinical trial of a single-blind, prospective and longitudinal randomized intervention comparing patients undergoing major cardiac surgery with extracorporeal circulation who are administered custodiol crystalloid cardioplegia versus buckberg blood cardioplegia.

myocardial protection by administering cardioplegia is a fundamental concept during cardiopulmonary bypass in patients undergoing cardiac surgery. it is a multifactorial strategy, in which cardioplegia is the most important. to date, there is no standardized consensus on the use of cardioplegia in different cardiac surgery procedures, and the best strategy continues to be debated given the wide range available. the choice of the type of cardioplegia should be made on an individual basis, taking into account the surgical procedure and clinical context. the need for a single dose of cardioplegia could favor the use of custodiol crystaloid cardioplegia in complex cardiac surgeries that require longer extracorporeal circulation time. both cardioplegia are safe and effective and widely used globally; however, the information provided in the literature is limited, with most of the information coming from retrospective studies.the objective of the present study is to demonstrate the non-inferiority of custodiol crystalloid cardioplegia versus buckberg blood cardioplegia in patients undergoing major cardiac surgery with extracorporeal circulation with prolonged aortic clamping times.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age. * patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping. exclusion criteria: 1. pregnancy. 2. aortic arch procedures. 3. procedures in which hypothermia \<28ºc is expected during the intervention. 4. minimally invasive procedures "port access". 5. active endocarditis. 6. emerging procedures. 7. isolated aortic valve replacements. 8. decision of the main surgeon not to participate in the study due to other clinical criteria.
robotic versus open comparison in the surgical treatment of wide abdominal wall hernias (rocstar)

Conditions: Ventral Incisional Hernia; Abdominal Wall Hernia

Summary: in the treatment of ventral incisional hernias, a mesh repair in the retromuscular plane is considered as the gold standard. to allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias, component separation techniques are increasingly being used. when compared to anterior component separation, posterior component separation by transversus abdominis release (tar) seems to decrease postoperative wound problems. while laparoscopic techniques pose significant difficulties to perform tar minimally invasively (mainly due to ergonomic and technical reasons), these limitations seem to be overcome by robotic platforms. initial retrospective patient series report on significantly shorter postoperative hospital stay and fewer complications after robotic transversus abdominis release (rtar), when compared to open transversus abdominis release (otar). high-quality prospective evidence on rtar is currently lacking.


Eligibility criteria:
inclusion criteria: - all patients requiring treatment of a wide ventral incisional hernia (of more than 8 centimetres in width) exclusion criteria: * pregnant or suspected pregnancy * not-curatively treated malignancy, with life expectancy less than 24 months * patients unable to give informed consent or complete study specific questionnaires * emergency surgery * primary ventral hernia repair * exclusively lateral hernias not involving the midline * incisional hernia repair after open abdomen or enterocutaneous fistula * active wound infection * previous anterior or posterior component separation * patients with an existing ostomy * patients with a life expectancy of less than 24 months * patients suspected of being unable to comply with the study protocol

Keywords: abdominal wall hernia robotic tar (rtar) open tar (otar) transversus abdominis release (tar)
effects of muscle energy versus counter strain technique on pain, function and satisfaction level in planter fasciitis

Conditions: Plantar Fasciitis

Summary: previous studies has discussed the effects of muscle energy technique and counterstrain technique in upper trapezius and low back pain but no comparative study is found on planter fasciitis patients. in this study we are going to compare the effects of muscle energy technique and counterstrain technique with routine physical therapy in relation with pain, functional status and satisfaction level in planter fasciitis patients

heel pain is one of the most prevalent musculoskeletal diseases of the lower limb, affecting both physically active and sedentary people. amongst the possible causes, planter fasciitis is one of the most common cause of heel pain. planter fasciitis is a degenerative syndrome resulting from the repeated injury at its origin on the calcaneus. its most common symptom is discomfort in the plantar area of the foot and, more specifically, in the inferior part of the heel. it is frequently more intense while taking your first steps in the morning or after a period of physical inactivity, and it worsens with prolonged standing or weight-lifting activities. it is not frequently linked to nocturnal discomfort or paresthesia. different physiotherapy treatment conventions help in pain relieving for example, rest, taping, stretching, orthosis-night brace, silicon heel cups and myofascial release. this study will compare the effects of muscle energy technique versus counterstrain technique in patients with plantar fasciitis.

Eligibility criteria:
inclusion criteria: * age 20 to 68 years. * both male and female. * patients are clinical diagnosed by the orthopedic surgeon. * patients present with pain that persist for more than 4 weeks in heel and planter surface of foot. * pain with the first steps after inactivity exclusion criteria: * • patients with history of ankle and foot fracture. * congenital or acquired deformity of ankle and foot. * patients with arthritis. * pervious history of surgery for planter fasciitis. * patients use an assistive device for walking. * patients use corticosteroid injection in heel.

Keywords: counterstrain, function, mets, pain, plantar fasciitis, satisfaction
comparison of intubating conditions in 25° head-up position and strict supine

Conditions: Intubation; Intratracheal

Summary: tracheal intubation, particularly before surgery, is traditionally done in supine position. it was shown in the general population and in obese patients in particular, that the pre-oxygenation in a 25° head-up position provided a better efficiency of the pre-oxygenation and an apnea time longer. this position would also allow for better intubation conditions in direct laryngoscopy. the investigators intend to assess two different patient's intubation position : supine position and 25° head-up position

randomization assigned in random block, stratification by operator (20 patients per operator, 10 in each group). interim analysis every 100 patients.

Eligibility criteria:
inclusion criteria: * - patients scheduled for various surgeries requiring general anesthesia with curare, with intubation of the trachea, eligible for intubation by direct laryngoscopy. * \> 18 years * patients with social security exclusion criteria: * emergency surgery. * patient who requiring rapid sequence induction. * intubation without curare. * expected difficult intubation with planned modification of the intubation protocol (i. e. intubation under fibroscopy, airtrach or videolaryngoscopy) * patient with a history of epilepsy, pulmonary or cardiovascular disease (including ischemic heart disease, symptomatic asthma or obstructive pulmonary disease). * patient with mask phobia. * bmi\> 30kg / m2 * patient who are refusing to take part. * patient protected major, minor, pregnant women, patients deemed incapable of giving informed consent.

Keywords: intubation conditions anaesthetic techniques laryngoscopy